In U.S. Pat. Nos. 4,744,364 and 4,852,568, assigned to the same assignee as this invention, there is disclosed an instrument and closure (plug) device for sealing an opening in tissue separating one portion of the body of a living being from another portion, e.g., a puncture in a blood vessel, duct or lumen, of a living being. Also disclosed are methods of use of that device. The instrument basically comprises an elongated tubular body having an outlet at its distal end. The distal end of the device is arranged to be inserted, such as percutaneously, through the puncture. In the case where the puncture is an artery or other blood vessel, the outlet is inserted through the puncture so that it is located within the blood vessel's interior. An expandable closure is disposed within the device's tubular body and is formed so that it is held in a compact or compressed configuration within the tubular body. The tubular body also includes an ejector in the form of a plunger-like member arranged to force the closure out of the outlet into the portion of the being's body contiguous with the opening, e.g., within the interior of the blood vessel, whereupon the closure automatically expands to form an enlarged tissue engagement surface.
A retraction filament is secured to the closure to enable it to be pulled fully into the puncture after the device's tubular body has been withdrawn so that the engagement surface of the closure intimately engages the inner surface of the tissue contiguous with the puncture.
In accordance with one aspect of the disclosure of those patents, the filament is held taut or otherwise secured and placed on the patient's skin to hold the closure in position in the puncture. Preferably, the closure and filament are each formed of some biodegradable material to enable them to be left in place. When the closure is used for sealing punctures or incisions in blood vessels it is constructed so that when it is open (i.e., in its expanded state) and in place sealing the puncture it doesn't appreciably block the flow of blood through the blood vessel.
In co-pending U.S. patent application, Ser. No. 194,641, filed on May 16, 1988, entitled Device For Sealing Percutaneous Puncture In A Vessel, which has been assigned to the same assignee as this invention there is disclosed another closure device for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being and a method of use of that device. That closure also comprises plug. However, that plug is formed of a material which when located within the puncture or incision expands automatically to engage the tissue contiguous therewith to seal the puncture and incision from the flow of body fluid therethrough. The closure is in the form of a holding member, a filament, and a sealing member. The holding member is an elongated body, constructed like a toggle, and preferably formed of a biodegradable, thermoplastic polymer, such as polyglactide. The toggle is molded onto the distal end of the filament. The filament is also biodegradable, and preferably formed of polyglactide suture. The filament, being flexible, enables the toggle to pivot to various orientations with respect to it. The sealing member basically comprises a cylindrical plug, preferably formed of a compressed foam, which is highly absorbent and which when disposed within the body swells in excess of its compressed diameter.
The closure is arranged to be used by an instrument to place it within the puncture or incision to be sealed. The instrument includes a tubular member in which the closure is disposed so that the toggle is oriented with its longitudinal axis parallel to the longitudinal axis of the tubular member. When so disposed the toggle compresses the portion of the distal end of the sealing member. The filament extends backward from the toggle through the sealing member.
The instrument is introduced into the puncture or incision in the artery or any body tissue (e.g., the liver, gall bladder, lung, heart, etc.) until its outlet is at the desired position. In the case of sealing an artery, the outlet of the instrument is positioned so that it is within the artery. The instrument is then operated to expel the closure member from the tubular member. Once the closure is expelled, the instrument is held in this position for a short period of time to allow the foam at the tip of the closure, that is the distal end portion of the closure, to swell. This action effectively tilts the toggle. The instrument may then be withdrawn and the closure's filament retracted. This action pulls the closure's plug portion back through the puncture or incision in the artery wall until its toggle portion engages the inner surface of the artery wall to stop further retraction. As the toggle comes into engagement with the arterial wall, it effects the compression of the distal end portion of the sealing member. Moreover, the proximal end portion of the sealing member extends into the puncture or incision in the subcutaneous tissue to a point closely adjacent the skin. These actions effectively seal the puncture or incision from the passage of blood therethrough. Other alternative embodiments of the automatically expanding plug are also disclosed in that patent application.
In co-pending U.S. patent application, Ser. No. 445,315, filed on Dec. 4, 1989, entitled Plug Device For Sealing Openings and Method of Use, assigned to the same assignee as this invention there is disclosed yet another closure (plug) device for use with an instrument for sealing a puncture or incision in tissue separating two internal portions of the body of a living being and a method of use of that device. That device basically comprises a closure or plug made up of a cordlike member and a thin filament. The cord-like member comprises a resorbable material and is folded in two to form an apex portion and a pair of wing portions extending therefrom. The plug's filament is secured to the apex portion. The plug is arranged for location within the instrument so that its apex portion is disposed adjacent the instrument's free end, and with its wing portions and its filament extending toward the proximally located portion of the instrument. The plug is arranged to be expelled partially from the tubular free end of the instrument so that its apex portion extends through the opening. After that is accomplished the filament is drawn in the proximal direction to cause the apex portion to engage the free end of the instrument to cause the cord-like member to form an expanded head having a peripheral, tissue-engagement surface. The plug is then drawn back through the opening so that the peripheral tissue engagement surface intimately engages the tissue contiguous with the opening.
While the closures (plugs) of the aforementioned patent applications are generally suitable for their intended purposes, they nevertheless exhibit certain drawbacks.
In U.S. Pat. No. 3,874,388 (King et al.) there is disclosed a device for closing off a septal defect or shunt in the vascular system of a living being. The device includes a pair of stainless steel, umbrella-like closures which are placed in position via use of a catheter. To that end one umbrella-like closure is inserted through the septal defect (opening) by one portion of the catheter and is expanded and pulled back into engagement with the tissue surrounding the opening on one side of the septum. The other closure is then introduced, expanded and then pushed into place by another portion of the catheter so that it is on the opposite side of the septum and engaging the tissue on that side of the septum.
The closure and catheter of the King et al. patent, appear quite complex in construction and not suitable for sealing various types of openings, e.g., small incisions or punctures in tissue, such as arteries, etc.
In Russian Patent No. 782,814 there is disclosed a prosthesis device arranged to be inserted through a defect (opening) in the septum of a living being. That device includes a one-piece resilient body having a reinforcement ring and a flat spring disposed within it. The spring member is arranged to be actuated by a rod to cause it to expand to the diameter of the ring and thereby bring the resilient body into sealing engagement with the opening.
The closure of the Russian patent appears to suffer from the same disadvantages as the King et al. patent.